Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

NCT06155305 | Recruiting

• 1 other identifier: 2023-0840
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common malignancy in women worldwide. Patients with breast cancer are often diagnosed at later stages and have a strong desire for breast conservation, necessitating neoadjuvant chemotherapy. Tumors of different molecular subtypes and individual variations among patients lead to significant differences in treatment efficacy. Precise assessment of patients' responses to treatment regimens is imperative in advancing prognosis of breast cancer. In this study, 58 patients diagnosed with breast cancer and scheduled for neoadjuvant therapy will be recruited. Patient-derived organoids from their tumor biopsies will be utilized to evaluate the sensitivity of chemotherapy regimen. These drugs primarily include Doxorubicin, Carboplatin, Cyclophosphamide, Paclitaxel, as well as targeted therapies such as Herceptin and Pertuzumab.

Conditions

Organoids; Breast Cancer; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes.

  The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.

  2023.12-2025.06

Secondary Outcomes (1)

• Comparison between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.

  2023.12-2025.06

Study Arms (1)

Breast cancer patients

Patients diagnosed with breast cancer undergo biopsy before initiating neoadjuvant therapy.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Before initiating neoadjuvant therapy, patients diagnosed with breast cancer undergo a tumor biopsy. The tissue obtained from the biopsy is utilized to establish organoids and conduct drug testing.

Breast cancer patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Male breast cancer is a rare disease.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with breast cancer (AJCC stages I to IIIA) who need to receive neoadjuvant therapy.

You may qualify if:

• Signed informed consent form and willingness to participate in the clinical study.
• Female patients aged between 18 and 70 years old.
• Confirmed early-stage breast cancer eligible for surgery (AJCC stages I to IIIA), with a tumor diameter of ≥ 2cm detected by MRI and without distant metastasis (M0).
• The largest lesion among multiple lesions has a diameter of ≥ 2cm.
• ECOG performance status score of 0-1.
• No significant abnormalities in liver and kidney function (BIL \<1.5-fold upper limit of normal (ULN)；ALT\<2.5×ULN; AST\<2.5×ULN；Crea≤1×ULN).

You may not qualify if:

• Received prior treatments.
• Locally advanced breast cancer not amenable to surgery or inflammatory breast cancer (AJCC stage unresectable III).
• Bilateral breast cancer.
• Multiple breast cancers distributed in different quadrants.
• Patients not suitable for neoadjuvant chemotherapy.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The primary tumor tissue and blood will be stored and used to identify potential biomarker for chemotherapy.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jian Huang

  2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

• Zhigang Chen

  2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHIGANG CHEN

CONTACT

+8657189713716; chenzg@zju.edu.cn

Jian Huang

CONTACT

+8657189713716; drhuangjian@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: December 6, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

CN (1)